Recently in Anesthesia Category

On May 7, 2015, Michigan Senator Mike Kowall (R-White Lake) introduced legislation that would allow hospitals more flexibility in determining the best anesthesia delivery model for their patient's needs. While certified registered nurse anesthetists ("CRNAs") provide the anesthesia care during most patient procedures - staying with the patient throughout the entire procedure - Michigan law still requires physician supervision of CRNAs. However, Michigan law does not even require the supervising physician to be an anesthesiologist or surgeon.

The proposed legislation would change this model and increase access to anesthesia care for Michigan patients in medically underserved rural and urban areas, while also containing anesthesia-related costs statewide. Under S.B. 320, Michigan hospitals could choose to keep the current physician-supervision model or move to a model that allows CRNAs to practice without mandatory physician supervision. If enacted, Michigan would join 40 other states that do not require physician supervision for CRNAs to administer anesthesia. The bill is currently in the Michigan Senate awaiting testimony before the Senate Health Policy Committee. More information on S.B. 320 may be found on the Michigan Legislature's website, available here.

On November 12, 2013, the Office of Inspector General (the "OIG") released an unfavorable Advisory Opinion in response to an anesthesiology practice's (the "Requestor") inquiry. Specifically, the OIG found that a psychiatry group's (the "Psychiatry Group") proposal to pay the Requestor a per-diem rate for anesthesia services while keeping any difference from the amount billed and collected could potentially violate the Anti-Kickback Statute ("AKS") by allowing the Psychiatry Group to keep such difference in return for referrals to the Requestor.

Background and Analysis

The Requestor was the exclusive provider of anesthesia services to the "Hospital" between 1993 and 2010. In December of 2010, the Psychiatry Group, co-owned by a physician who was board certified in both psychiatry and anesthesia, relocated to the Hospital. During renegotiations of the Requestor's exclusivity contract in 2011, the Hospital insisted that the contract include a carve-out of anesthesia services for electroconvulsive therapy ("ECT") procedures, which would be provided by the Psychiatric Group's co-owner when those procedures were provided by the Psychiatric Group. In 2012, the Hospital expanded the carve-out to include all ECT provided at the Hospital and added a requirement that the Requestor enter "good faith negotiations" with the Psychiatric Group to provide the ECT anesthesia services if the Psychiatric Practice and/or the Hospital determined that a second provider was required ("Additional Anesthesiologist Provision").

After the 2012 contract went into effect, the Psychiatric Group determined that a second provider was required and submitted a proposal under the Additional Anesthesiologist Provision whereby a Requestor physician would furnish ECT anesthesia services on a part-time basis. The Requestor physician would be required to reassign its billing rights for the ECT services to the Psychiatric Group who would, in turn, bill and collect for such services. The Psychiatric Group would pay a per diem rate to the Requestor and retain the difference between the per diem and the amount collected. Because the aggregate compensation over the course of the agreement was not set in advance and, at least according to the Requestor, was not fair market value ("FMV"), the proposed agreement did not satisfy the Personal Services Safe Harbor to the AKS. Furthermore, the OIG explained that "the safe harbor protects only those payments made by a principal (here, the Psychiatry Group) to an agent (here, Requestor); no safe harbor would protect the remuneration Requestor would provide to the Psychiatry Group."

The OIG determined that there was more than a minimal risk that the proposal would generate unlawful remuneration for the Psychiatric Group. Specifically, the difference between the per diem rate paid to Requestor and the amount billed and collected for the services could serve as a fee for referring the services to the Requestor.

While the OIG does not otherwise discuss or offer its opinion on the relationships between the Hospital and either of the physician practices at issue, Footnote 5 seems to allude to the possibility that the Hospital's inclusion of the Additional Anesthesiologist Provision in the 2012 agreement may itself be suspect. Specifically, the OIG seemed concerned that:

i) the Hospital used the provision as a way of compensating the Psychiatry Group for its continued referral of ECT procedures;
ii) the Hospital used its leverage over the referrals to the Requestor as a way of securing the provision; and/or
iii) Requestor agreed to the Additional Anesthesiologist Provision in exchange for the exclusivity arrangement.
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Non-anesthesia provider groups seeking to offer the services of an anesthesia provider or anesthesia group should seek the advice of their health care legal counsel to ensure that the relationships are structured in compliance with applicable fraud and abuse laws and to minimize legal risk.

42 C.F.R. § 410.69, which went into effect January 1, 2013, defines and sets forth the requirements for certified registered nurse anesthetists ("CRNAs") and anesthesiologist's assistants ("AAs"). § 410.69 defines "Anesthesia and related care" as "those services that a certified registered nurse anesthetist is legally authorized to perform in the state in which the services are furnished." An "Anesthetist" encompasses both CRNAs and AAs.

• Defined "Anesthetist" consistent with 42 C.F.R. § 410.69, including CRNAs and AAs
• Added "nonphysician" as clarification to the term anesthetist
• Removed the applicable CRNA conversion factor from the calculation of the anesthesia services fee schedule for services on or after January 1, 1996 (i.e. after that date, the applicable CRNA conversion factor is no longer used in determining the fee schedule)
• Added "reasonable and necessary" to the medical or surgical services performed by CRNAs which will be paid for by CMS

Transmittal 2668 replaced Transmittal 2634, keeping all changes, but removing Sections 140.1.1 and 140.1.2, which were inadvertently retained by Transmittal 2634. These sections related to notifications/verifications of certification and renewal of certification of CRNAs and AAs by and between CMS, employers of CRNAs/AAs, and carriers. All other changes made by 2634 were retained by 2668.

Payment shall be made for reasonable and necessary medical or surgical services furnished by CRNAs if they are legally authorized to perform these services in the state in which services are furnished. Payment is determined under the physician fee schedule on the basis of the national physician fee schedule conversion factor, the geographic adjustment factor, and the resource-based relative value units for the medical or surgical service.

On September 25, Senator Michael Green (31st District) introduced a bill that would expand the definition of the practice of nursing to include "administration of anesthesia by a registered professional nurse who holds a specialty certification as a nurse anesthetist." Senate Bill 1309 was referred to the Senate Health Policy Committee after two readings. Presently, nurse anesthetists in Michigan are required to have physician supervision. The practical effect of the bill would be to explicitly expand the scope of practice of nursing to include administration of anesthesia, thereby negating the need for physician supervision. Because physician supervision is mandated only in the practice of medicine, by fitting administration of anesthesia into the practice of nursing, nurse anesthetists would have direct (as opposed to delegated) authority to administer anesthesia.

Senate Bill 1309 is just another example of the trend of expanding the realm of non-physician healthcare providers driven by economic and legislative pressure.

Within the next month, the Centers for Medicare and Medicaid Services (CMS) is expected to finalize the proposed Medicare Physician Fee Schedule for 2013. In the rule, CMS proposes to expand the definition of CRNA services to include "medical and surgical services that are related to anesthesia and that a CRNA is legally authorized to perform by the State in which the services are furnished." Recognizing that several state legislatures have passed or are contemplating legislation that includes pain management within the scope of practice of Certified Registered Nurse Anesthetists (CRNAs), CMS rationalized its proposed changes on the basis that its new definition of CRNA services would allow for flexible application to the varying scopes of practice across states.

In recent years, as the specialty of pain management developed and the scope of CRNA practice evolved, there has been a lack of clarity and uniformity in how Medicare Administrative Contractors (MACs) interpreted the Medicare provisions relating to CRNA services that qualified for reimbursement. The proposed 2013 Physician Fee Schedule establishes a definitive answer. Essentially, if the fee schedule is passed as proposed, CRNAs will be reimbursed for those pain management services provided that are within the scope of their practice as defined by the state in which they practice. CMS cautions, however, that not all CRNAs practicing in states that permit CRNAs to perform pain management services have the requisite education or training. As with all other practitioners, CRNAs are responsible for obtaining the necessary training for all services furnished to Medicare beneficiaries.

The proposed rule triggered a nationwide grassroots opposition campaign by the American Society of Anesthesiologists (ASA). Citing the complexity of chronic pain procedures and advanced education and training required for safe administration of medication therapies, the ASA contends that current restrictions on CRNAs are in the best interest of patient safety. Conversely, the American Nursing Association (ANA) asserts that accreditation standards for CRNA programs include advanced education and training in treatment of chronic pain sufficient to develop proficiency in pain management practice. With the proliferation of mid-level practitioners in recent years, driven by a strained economy and propelled by healthcare reform, the scope of practice of non-physician providers will continue to evolve. CMS's proposed 2013 Physician Fee Schedule represents simply another instance of this process.

On June 13, 2012, the California Supreme Court unanimously denied review in the case of California Society of Anesthesiologists v. Superior Court, 204 Cal.App.4th 390 (1st Dist. 2012) ending an over two year battle by the California Society of Anesthesiologists and the California Medical Association who challenged former governor Arnold Schwarzenegger's certification to the federal government that California law allowed Certified Registered Nurse Anesthetists (CRNAs) to administer anesthesia without physician supervision.

Medicare regulations require physician supervision of CNRAs as a condition of receiving Medicare reimbursement. 42 C.F.R. §§ 482.52(a)(4); 485.639(c)(2); 416.42(b)(2). However, additional Medicare regulations allow a state to opt out of the physician supervision of CNRAs requirement. In order to opt out of the physician supervision requirement, the state's governor must submit a letter to the Centers for Medicare and Medicaid Services (CMS) requesting an exemption. The letter "must attest" that the governor has: (1) consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State; (2) concluded that it is in the "best interests of the State's citizens" to opt out of the current federal physician supervision requirement; and (3) concluded that the opt out is "consistent with State law." 42 C.F.R. §§ 482.52(c)(1), 485.639(c)(1), 416.42(c)(1). Former Governor Schwarzenegger opted California out of this requirement on June 10, 2009, finding that California law allowed CNRAs to administer anesthesia without physician supervision.
The California Society of Anesthesiologists and the California Medical Association challenged the certification by Schwarzenegger and argued that California law did not allow CNRAs to administer anesthesia without physician supervision. The California Nursing Practice Act provides that CRNAs are authorized to administer medications necessary to implement treatment "ordered" by a physician. West's Ann.Cal.Bus. & Prof.Code § 2725(b)(2).

The trial court which heard the case found that the Nursing Practice Act allowed CNRAs to administer anesthesia without physician supervision. On appeal to the California First District Court of Appeals, the appellate court likewise found that the plain language of the Nursing Practice Act authorizes CRNAs to administer anesthesia without physician supervision. The appellate court also relied on the conclusion reached by the Board of Registered Nursing and other agencies and officials, including the State Attorney General and denied the challenge by California Society of Anesthesiologists and the California Medical Association.

Fifteen other states have opted out of the Medicare requirement requiring CNRAs to be supervised by a physician while administering anesthesia: Washington, Oregon, Iowa, Nebraska, Idaho, Minnesota, New Hampshire, New Mexico, Kansas, North Dakota, Alaska, Montana, South Dakota, Wisconsin, and Colorado.

On June 1, 2012, the Department of Health and Human Services Office of Inspector General (the "OIG") issued its Advisory Opinion No. 12-06, which provides long-awaited guidance to the health care industry regarding the legal permissibility of an anesthesia delivery service model commonly referred to as the "company model." Insofar as Advisory Opinion No. 12-06 is the initial OIG guidance that specifically focuses on such an arrangement and determines that the factual paradigms presented implicate risks under the Medicare and Medicaid Antikickback Statute (the "AKS"), this Advisory Opinion understandably is capturing broad attention within the medical and legal communities. While OIG Advisory Opinion 12-06 clarifies the almost-axiomatic observation that company model arrangements, especially those that contain the indicia that the OIG historically has identified as problematic under the AKS, certainly have the potential to violate the AKS, the legal permissibility of each company model arrangement should continue to be analyzed based upon each arrangement's unique facts and circumstances. Stated otherwise, OIG Advisory Opinion 12-06 should not be interpreted to mean that all company model frameworks necessarily are violative of the AKS; rather, the Advisory Opinion reinforces the consistent guidance provided by The Health Law Partners that these arrangements need to incorporate the requisite structural safeguards.

Broad Overview of Company Model Arrangements and Related Controversy

A significant percentage of ASC procedures involve anesthesia services provided by an anesthesiologist or a certified registered nurse anesthetist ("CRNA"). Due to changes within the health care environment, including, in particular, contraction to reimbursement and an increased emphasis on quality and efficiency of patient care, an increasing number of ASCs around the country have transformed their relationships with the anesthesia providers from the normative arrangement (under which an independent anesthesia group bills fee-for-service for the anesthesia services that it furnishes at the ASC) to "company model" arrangement. Although there are a number of permutations of the structure, the company model generally involves the ASC or some or all of its physician owners (hereafter, in either case, the "ASC Physician Members") establishing a separate legal entity that will provide anesthesia services to the ASC by employing or contracting with anesthesia providers (the "New Company"). The New Company separately bills for the anesthesia services and then pays the anesthesia providers an agreed-upon rate (or contractual compensation in the case of employed anesthesiologists). As a result, the ASC Physician Members capture a portion of the anesthesia revenue generated from procedures furnished at the ASC (which, under the traditional paradigm, had been exclusively realized by the anesthesiologists).

The company model debate has prompted vigorous discussion within the health care bar. The legal dialogue, in particular, focuses upon the application of the AKS to the company model structure. In pertinent part, the AKS prohibits anyone from knowingly and willfully soliciting, receiving, offering or paying remuneration, in cash or in kind, to induce or in return for referrals of items or services payable by any federal health care program. Liability is imposed upon both parties to an impermissible transaction. The AKS has been interpreted to cover any arrangement where one purpose of the remuneration is to obtain money for referral of services or to induce further referrals, even if other salutary purposes exist. Violation of the AKS constitutes a felony punishable by a maximum fine of $25,000, imprisonment up to five years or both. Conviction will also lead to automatic exclusion from federal health care programs, including Medicare and Medicaid and may result in the imposition of civil monetary penalties.

In the company model context, the profit that the ASC Physician Members derive from the anesthesia revenue at the ASC, in an improperly structured arrangement, potentially represents impermissible remuneration in the AKS context. In its most basic terms, the issue is whether, in substance, the ASC Physician Members are "converting their referral stream into a revenue stream." The theory is that the anesthesiologists would essentially be required to forego the anesthesia profit (in favor of the New Company) in exchange for the ability to provide (or, in the case of a then-current anesthesia provider, continue providing) anesthesia services at the ASC, and the ASC Physician Members would earn such profit, based in part, upon their referrals of such services to the anesthesiologists. As discussed below, the fact that the company model affords the ASC Physician Members the ability to capture anesthesia revenue, by itself, does not violate AKS insofar as the determinative element of any AKS violation is impermissible intent. Further, the Federal government is particularly concerned with arrangements that have the ability to negatively affect patient care and/or to result in overutilization. OIG Advisory Opinion No. 12-06 states "[t]he anti-kickback statute seeks to ensure that referrals will be based on sound medical judgment, and that health care professionals will compete for business based on quality and convenience, instead of paying for referrals." Any AKS analysis requires consideration of the aggregate facts and circumstances in light of available Federal guidance.

In our view, OIG Advisory Opinion No. 12-06 should be seen as corroborative of the AKS principles that the OIG has articulated in prior guidance. Thus, there is no unique company model jurisprudence. Rather, to the extent that a company model arrangement contains the suspect indicia that the OIG has consistently identified, then such an arrangement will assume a higher level on the risk spectrum, whereas, by contrast, company models that both demonstrate a clearer nexus between the ASC Physician Members and New Company's business (especially in the form of active participation, particularly focused towards the elevation of clinical care), and which avoid correlations between distributions to the ASC Physician Members and their referrals, the risks will be comparatively lower.

Recent OIG Advisory Opinion No. 12-06 and HLP Comments

In OIG Advisory Opinion No. 12-06, the OIG reviewed two proposals (i.e., Proposal A and B) (the "Proposed Arrangements") for modifying the relationship between certain ASCs and their exclusive provider of anesthesia services (the "Requestor") and determined that both of the Proposed Arrangements could potentially violate AKS and result in administrative sanctions.

At the outset, we note that Proposal A itself is not truly a "company model" arrangement. Proposal A involved the Requestor continuing to serve as the exclusive provider of anesthesia services and to bill and retain collections for its services, subject, however, to the requirement that it would pay the ASCs a per-patient fee for certain "management services" with respect to non-federal health care program patients. The OIG clarified that the proposed "carve out" of federal health care program patients is does not insulate the otherwise-defective structure from AKS scrutiny. The Federal government would view the relationship between the Requestor and the ASCs (which also included the provision of services to federal health care program patients) as a whole. The OIG noted that the ASCs were already essentially paid for such management services through the facility fee that the ASCs receive from Medicare and therefore, under Proposal A, the ASCs would be paid twice for the same services. Further, such management fee would have the potential to inappropriately dictate which anesthesia provider was selected by the ASC. The OIG's disapproval of Proposal A reaffirms the position that HLP has consistently taken that conditioning a provider's (e.g., an anesthesiologist's) right to perform services upon entry into a contractual arrangement with a group of physicians who potentially control the referrals to such provider (e.g., ASC Physician Members) can implicate substantial regulatory risks.

In contrast to Proposal A described above, Proposal B represents a more normative variant of company model arrangement (albeit one against which we have counseled). Under Proposal B, the ASC Physician Members would indirectly (through their professional entities or the ASC itself) own a new subsidiary entity (the "Subsidiary"). The Subsidiary would engage the Requestor as an independent contractor to provide a broad (i.e., substantially the full spectrum of required) anesthesia-related administrative services through the new Subsidiary entity in return for a negotiated fee. Further, the Subsidiary would employ anesthesia providers (some or all of whom would be affiliated with Requestor) or contract with the Requestor's anesthesia providers on a contractor basis. The Subsidiary would furnish and bill for all anesthesia services provided at the ASC and pay the anesthesia providers agreed-upon compensation. Simply stated, insofar as the ASC Physician Members would indirectly own the Subsidiary, there would be a correlation between the number of procedures performed at the ASC that require anesthesia and the profit distributions to the ASC Physician Members from the Subsidiary. (It should be noted, in the context of this discussion, that such correlation between referrals and profit distributions exists in legally permissible in-office ancillary service arrangements, even among single specialty group practices.) Among other factors, the OIG also found it significant that the ASC physicians would not be involved in the operations of the Subsidiary and that substantially all of the operations would be contracted out to Requestor. Further, it is noteworthy that the anesthesia services would be provided by the same provider that historically furnished the anesthesia services before entry into the company model arrangement. Relying heavily upon its previously issued joint venture guidance, the OIG concluded that Proposal B would pose "more than a minimal risk of fraud and abuse."

The OIG's conclusions with respect to Proposal B are consistent with the advice that HLP has previously provided: if a company model arrangement (such as Proposal B) is implemented (or appears to be implemented) to convert referrals (by ASC physicians to anesthesiologists) to a revenue stream and to incentivize overutilization and undue influence over choice of anesthesia provider, such company model involves a high level of risk and is likely impermissible. Factors that increase the risk of inappropriate utilization through the ordering of unnecessary procedures and anesthesiology services to generate revenue have the ability to increase costs to the federal health care programs, interfere with clinical decision-making and raise patient safety or quality of care concerns. By contrast, if a company model arrangement is organized and operated for legally permissible goals (i.e., improving quality and efficiency of care), the ASC Physician Members participate actively in the business' conduct, and the profit distribution mechanism does not bear a connection between distributions and the ability to generate procedures, its legal risk is significantly mitigated and the arrangement is in a far better position to be defensible, especially if all the requisite structural safeguards are included.

Conclusion

OIG Advisory Opinion No. 12-06 reminds us that company model arrangements must include meaningful safeguards to mitigate legal risk and to be defensible from an AKS perspective. That being said, the value of such safeguards depends upon the manner in which they are implemented and the actual intent that underlies their inclusion.

Any company model arrangement must be structured, and most importantly, actually implemented, in a good faith manner and involve circumstances that reflect good intent, such as improving quality, efficiency and coordination of care or other permissible purposes. Meaningful efforts to coordinate care through increased integration and alignment among providers is a favorable factor. Employment of the anesthesiologists and CRNA's by the new ASC or physician owned anesthesia entity would promote such a nexus. Further, if the objective of the new entity is genuinely to improve quality and efficiency, all the physician owners should be meaningfully engaged in the operations of the Company, especially with regard to the development and continuous refinement to policies and protocols (e.g., "best practices") designed to enhance the quality and efficiency of services furnished at the ASC.

We also take the opportunity to emphasize that distributions from the new company under a company model arrangement to the physician owners (directly or indirectly) should be made in accordance with such physicians' respective ownership interests (or some other factor unrelated to referrals) and certainly not based upon the number of procedures they perform at the ASC. Accordingly, it is imperative that such new company not determine the ownership interests of the physicians based upon their anticipated referrals or business generated, not encourage physician investors to divest their ownership interest if they fail to generate a certain level of referrals or business generated, and not track the source of referrals to or business generated for the company.

On July 19, 2011, the Centers for Medicare and Medicaid Services ("CMS") published in the Federal Register its CY 2012 Physician Fee Schedule Proposed Rule ("Proposed Rule"). On November 1, 2011, CMS issued its 2012 Final Physician Fee Schedule ("Final Rule"), in part, to "address changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services." Some key provisions of the Final Rule are set forth below:

Payment Reduction Pursuant to the Sustainable Growth Rate - Payments to providers under the Medicare Physician Fee Schedule is set to be reduced by 27.4%, as required by the Sustainable Growth Rate formula, beginning January 1, 2012 absent legislative measures to block to reduction.

Addition of Certain Telehealth Services - Generally speaking, CMS reimburses providers for telehealth services--located at a distant site--furnished to an eligible telehealth beneficiary in an originating site. In the Final Rule, CMS proposes adding smoking cessation services to the services to the list of Medicare telehealth services, but notably, chose not to include online evaluation and management ("E&M") services (i.e., to add CPT code 99444) because "(1) these services are non-face-to-face; and (2) the code descriptor includes language that recognizes the provision of services to parties other than the beneficiary and for whom Medicare does not provide coverage (for example, a guardian)."

Expansion of the Multiple Procedure Payment Reduction ("MPPR") - The MPPR has been expanded to include the professional component of certain advanced diagnostic imaging services. For a more detailed explanation of this change, please see this blog entry.

Anesthesia Fee Schedule Conversion Factor - For 2012, the anesthesia conversion factor is $24.6712 with the national average anesthesia conversion factor equal to $15.5264, a decrease of 26.2% from 2011.

Additions to the Physician Self-Referral List of CPT/HCPCS Codes - Beginning January 1, 2012, the following tables provide the codes will be added and removed as designated health services ("DHS") for purposes of the physician self-referral law (a/k/a the Stark Law):

On May 20, 2011, Ohio governor, John Kasich, signed Ohio House Bill 93 into law. The bill represents an effort by Ohio to strengthen the State's regulatory framework relating to the prevention of prescription drug abuse. According to the Ohio Department of Health, since 2007, unintentional drug overdoses in the state accounted for more accidental deaths than motor vehicle crashes and suicides combined.

The new law, when it becomes effective, is expected to transform the landscape for the operation of pain management clinics in the State of Ohio. The bill mandates the State Board of Pharmacy to license pain management clinics and, further, provides for the clinics to be licensed as terminal distributors of dangerous drugs with a pain management clinic classification. Moreover, the law will prohibit the operation of a pain clinic without such a license. (The prohibition, however, will be postponed until 30 days following the bill's effective date). The bill also mandates the State Medical Board to implement rules establishing standards for physicians who provide care at pain management clinics and guidance for the physician operation of such clinics. Finally, the bill also authorizes the State Board of Pharmacy to levy fines (up to $5,000) against pain management clinics and/or the State Medical Board to impose fines (up to $20,000) for failure to comply with the rules of operation or standards for distributors of dangerous drugs with a pain management classification established under the act.

Earlier this month, Transmittals to the State Operations Manual for ASCs (Appendix L) implemented certain clarifications/changes to the anesthetic risk assessment, H&P and pre-surgical evaluation Conditions of Participation at ASCs, effective 5.13.11. The new standards from the Transmittal are set forth below, followed by the provisions in which these new standards of Appendix L have been incorporated.

1. Anesthetic Risk Assessment: When the comprehensive H&P assessment is performed in the ASC on the same day as the surgical procedure, the Transmittal indicates that the assessment of the patient's procedure/anesthesia risk must be conducted separately from the history and physical, including any update assessment incorporated into that history and physical.

2. H&Ps:

a. The H&P (conducted within 30 days of the scheduled surgery) must be comprehensive in order to allow assessment of the patient's readiness for surgery and, as clarified by the Transmittal, is required regardless of the type of surgical procedure.

b. While the comprehensive H&P may be performed in the ASC on the same day as the surgical procedure (provided that it is conducted by qualified personnel, is comprehensive, and the results of the H&P are placed in the patient's medical record prior to the surgical procedure), according to the Transmittal, it is not acceptable to conduct the H&P after the patient has been prepped and brought into the operating or procedure room. The rationale for this requirement is that the purpose of the H&P is to determine, prior to surgery, whether there is anything in the patient's overall condition that would affect the conduct of, or possibly require cancellation of, the planned procedure.

3. Pre-Surgical Assessment:

a. Independent of the H&P requirement discussed above, upon admission to the ASC each ASC patient must have a pre-surgical assessment by a physician to evaluate the risk of the anesthesia and of the procedure for that patient. The Transmittal notes that this component must be conducted by a physician, immediately prior to surgery, and must be performed in a manner consistent with the anesthetic risk assessment requirements discussed in paragraph 1 above.

b. In accordance with the Transmittal, if the H&P is performed on the day of the surgical procedure in the ASC, some, but not all, elements of the pre-surgical assessment may be incorporated into the H&P. However, the assessment of the patient's risk for the procedure and anesthesia (as discussed in paragraph 1 above) must still be conducted separately, by a physician and immediately prior to surgery.

§416.42(A) STANDARD: ANESTHETIC RISK AND EVALUATION
(1) A physician must examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed.
Interpretive Guidelines: §416.42(a)(1)

The purpose of the exam immediately before surgery is to evaluate, based on the patient's current condition, whether the risks associated with the anesthesia that will be administered and with the surgical procedure that will be performed fall within an acceptable range for a patient having that procedure in an ASC, given that the ASC does not provide services to patients requiring hospitalization. The assessment must be specific to each patient; it is not acceptable for an ASC to assume, for example, that coverage of a specific procedure by Medicare or an insurance company in an ASC setting is a sufficient basis to conclude that the risks of the anesthesia and surgery are acceptable generically for every ASC patient. The requirement for a physician to examine the patient immediately before surgery is not to be confused with the separate requirement at 42 CFR 416.52(a)(1) for a history and physical assessment performed by a physician, although it is expected that the physician will review the materials from such pre-admission examination as part of the evaluation. Nevertheless, this requirement does constitute one component of the requirement at 42 CFR 416.52(a)(2) for a pre-surgical assessment upon admission. In those cases, however, where the comprehensive history and physical assessment is performed in the ASC on the same day as the surgical procedure, the assessment of the patient's procedure/anesthesia risk must be conducted separately from the history and physical, including any update assessment incorporated into that history and physical. See the interpretive guidelines for§§416.52(a)(1) & (2).

The ASC must have approved policies and procedures to assure that the assessment of anesthesia-related and procedural risks is completed just prior to every surgical procedure. (Ideally, the ASC would conduct such an assessment prior to the patient's admission as well as immediately prior to surgery, but this is not specifically required by the regulations.)

The ASC‟s policies must address the basis or criteria used within the ASC in conducting these risk assessments, and must assure consistency among assessments.
The regulations do not specify the content or methodology to be employed in such assessments. As an illustrative example, an ASC might choose to incorporate consideration of a patient's ASA Physical Classification into its criteria. Although the American Society of Anesthesiologists did not create its ASA Physical Status Classification System for the purpose of predicting operative risk, this system has nevertheless been found to be useful in predicting morbidity and mortality in surgical patients1 and has been used by surgical facilities as a standard tool. This system classifies patients‟ physical status in 6 levels:

As the ASA PS level of a patient increases, the range of acceptable risk associated with a specific procedure or type of anesthesia in an ambulatory setting may narrow. An ASC that employed this classification system in its assessment of its patients might then consider, taking into account the nature of the procedures it performs and the anesthesia used, whether it will accept for admission patients who would have a classification of ASA PS IV or higher. For many patients classified as ASA PS level III, an ASC may also not be an appropriate setting, depending upon the procedure and anesthesia.

If a State establishes licensure limitations on the types of procedures an ASC may perform that are based on patient classifications and would permit ASCs to perform fewer procedures than they would under the CfCs, then the ASC must conform to those State requirements. However, State requirements that would expand the types of procedures an ASC may offer beyond what is permitted under the CfCs are superseded by the Federal CfC requirements.
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§416.52(A) STANDARD: ADMISSION AND PRE-SURGICAL ASSESSMENT
(1) Not more than 30 days before the date of the scheduled surgery, each patient must have a comprehensive medical history and physical assessment completed by a physician (as defined in section 1861(r) of the Act) or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy.
Interpretive Guidelines §416.52(a)(1)

The purpose of a comprehensive medical history and physical assessment (H&P) is to determine whether there is anything in the patient's overall condition that would affect the planned surgery, such as a medication allergy, or a new or existing co-morbid condition that requires additional interventions to reduce risk to the patient, or which may even indicate that an ASC setting might not be the appropriate setting for the patient's surgery. The H&P must be comprehensive in order to allow assessment of the patient's readiness for surgery and is required regardless of the type of surgical procedure. The H&P
should specifically indicate that the patient is cleared for surgery in an ambulatory setting.

The H&P must be completed and documented for each ASC patient no more than 30 calendar days prior to date the patient is scheduled for surgery in the ASC.
In cases where the patient is scheduled for two surgeries in the ASC within a short period of time, the same H&P may be used so long it is completed no more than 30 calendar days before each surgery. For example, if a patient has two surgeries for cataracts scheduled, one eye on May 3rd, and the other eye on May 18th, and H&P performed on April 20th could be used for both surgeries.

The H&P is still required in those cases where the patient is referred to the ASC for surgery on the same day as the referral and the referring physician has indicated it is medically necessary for the patient to have the surgery on the same date. The H&P may be performed by the referring physician, if the ASC‟s policies permit this, or qualified personnel in the ASC. If there are elements of the H&P that are essential to the performance of the physician assessment required under §416.42(a) or under this requirement at §416.52(a)(1), based on the type of procedure to be performed as well as applicable State health and safety laws, standards of practice, or ASC policy, and those elements cannot be completed prior to the scheduled time of the surgical procedure, then it is questionable whether the case is suitable for that ASC.

The H&P may be performed on the same day as the surgical procedure, and may be performed in the ASC, as long as it is conducted by qualified personnel, is comprehensive, and the results of the H&P are placed in the patient's medical record prior to the surgical procedure (see §416.52(a)(3). It is not acceptable to conduct the H&P after the patient has been prepped and brought into the operating or procedure room, since the purpose of the H&P is to determine before the surgery whether there is anything in the patient's overall condition that would affect the conduct of the planned procedure, or which may even require cancellation of the procedure.

The medical history and physical examination must be completed and documented by a physician (as defined in Section 1861(r) of the Act) or other qualified licensed individual practitioner in accordance with State law, generally accepted standards of practice, and ASC policy.

Section 1861(r) defines a physician as a:

doctor of medicine or osteopathy;
doctor of dental surgery or of dental medicine;
doctor of podiatric medicine;
doctor of optometry; or a
chiropractor.

In all cases the practitioners included in the definition of a physician must be legally authorized to practice within the State where the ASC is located and providing services within their authorized scope of practice.

Other qualified licensed individuals are those licensed practitioners who are authorized in accordance with their State scope of practice laws or regulations to perform an H&P and who are also formally authorized by the ASC to conduct an H&P. Other qualified licensed practitioners could include nurse practitioners and physician assistants.
More than one qualified practitioner can participate in performing, documenting, and authenticating an H&P for a single patient. When performance, documentation, and authentication are split among qualified practitioners, the practitioner who authenticates the H&P will be held responsible for its contents.
In the case of an ASC the H&P is typically completed by the patient's primary care practitioner rather than a member of the ASC‟s medical staff. The ASC‟s policy on H&Ps should address submission of an H&P prior to the patient's scheduled surgery date by a physician who is not a member of the ASC‟s medical staff and should indicate whether it will accept H&Ps performed by a qualified licensed individual who does not practice at the ASC but is acting within his/her scope of practice under State law or regulations.

§416.52(A) STANDARD: ADMISSION AND PRE-SURGICAL ASSESSMENT
(2) Upon admission, each patient must have a pre-surgical assessment completed by a physician or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy that includes, at a minimum, an updated medical record entry documenting an examination for any changes in the patient's condition since completion of the most recently documented medical history and physical assessment, including documentation of any allergies to drugs and biologicals.

Interpretive Guidelines: §416.52(a)(2)

Each ASC patient upon admission to the ASC must have a pre-surgical assessment. The requirement at §416.42(a)(1) for a physician to examine the patient immediately before surgery to evaluate the risk of the anesthesia and of the procedure for that patient is one component of the requirement at 42 CFR 416.52(a)(2). This component must be conducted by a physician, immediately prior to surgery, and must be performed in a manner consistent with the requirements at §416.42(a)(1). (See the interpretive guidelines for §416.42(a)(1). Other elements of the assessment may be conducted by a licensed practitioner who is credentialed and privileged by the ASC to perform an H&P. In all cases, the update must take place prior to the surgery.

If the H&P required under §416.52(a)(1)is performed on the day of the surgical procedure in the ASC, some, but not all, elements of the pre-surgical assessment may be incorporated into the H&P. However, the assessment of the patient's risk for the procedure and anesthesia required under §416.42(a)(1) must still be conducted separately, by a physician and immediately prior to surgery.

The patient must be assessed for any changes in his/her condition since the patient's H&P was performed that might be significant for the planned surgery. Patients may have had a change in health status after the H&P, but may not recognize the significance for their planned surgery. Any changes in health and medication can have an impact on the patient's ability to tolerate the surgery or anesthesia, and the post-admission pre-surgical assessment is designed to identify these changes and take appropriate action, up to and including postponing or cancellation of the surgery. In addition, the pre-surgical assessment must identify and document any allergies the patient may have to drugs and biologicals, or indicate that the patient has no known allergies to drugs and biologicals.

Further, if the practitioner finds that the H&P done before admission is incomplete, inaccurate, or otherwise unacceptable, the practitioner reviewing the H&P, examining the patient, and completing the update may disregard the existing H&P, and conduct and document in the medical record a new H&P prior to the surgery.
The patient's medical record must include documentation that the patient was examined prior to the commencement of surgery for changes since the H&P. The physician or qualified licensed individual uses his/her clinical judgment, based upon his/her assessment of the patient's condition and co-morbidities, if any, in relation to the patient's planned surgery to decide the extent of the update assessment needed as well as the information to be included in the update note in the patient's medical record.

If, upon examination, the licensed practitioner finds no change in the patient's condition since the H&P was completed, he/she may indicate in the patient's medical record that the H&P was reviewed, the patient was examined, and that "no change" has occurred in the patient's condition since the H&P was completed. Likewise, any changes in the patient's condition must be documented by the practitioner in the update note prior to the start of surgery.

May 10, 2011, the Miami Lakes, Florida council passed a zoning ordinance requiring pain clinics in its town to obtain a special permit. A pain clinic's grand opening advertisement featuring the words "pain" and "opiates" put a Miami Lakes councilman in fear of potential pill-mill activity coming to town and prompted the council's efforts to pass the ordinance.

The fear is not completely ungrounded. South Florida has been called the "national epicenter" of the funneling of illegal prescription drugs, and law enforcement officials' recent raids have targeted the area. Broward County, located only a few miles from Miami Lakes, in particular has significantly contributed to the nation's pill-mill problem.

The Miami Lakes zoning ordinance would allow the town two to three months to review a pain clinic's application. The ordinance also prohibits anyone operating or owning a pharmacy in town from running a pain clinic, requires special zoning approval to establish a new pain clinic within 500 feet of another clinic, and requires all current town medical offices, labs, and clinics to register with the town and provide detailed information within six months.

The existence of some pain mills places all pain physicians under greater scrutiny. As such, it is vital for well-intentioned pain management physicians to proactively protect themselves.

In an effort to better educate the anesthesia community with regard to the impact of Accountable Care Organizations ("ACOs") on the specialty, the ASA Ad Hoc Task Force on ACOs has been carefully analyzing the March 31, 2011 ACO proposed regulations. As a preliminary step, at the end of April 2011, the ASA released 21 FAQs relative to ACOs. The ASA also plans to continually update the FAQs as new information emerges. The ASA FAQs can be accessed here.

South Florida has been called the "national epicenter" for the illegal dispensing of prescription drugs. Law enforcement officials have targeted South Florida for quite some time, with February 23 being no exception. On February 23, law enforcement officials and Drug Enforcement Agency (DEA) agents raided six pain clinics accused of illegally dispensing prescription drugs, arresting 22 people--five of who were doctors.

While most pain physicians do not conduct pill mills, because of the few that do, all pain physicians are subject to increased scrutiny. As such, it is important for well-intentioned pain management physicians to proactively protect themselves. For example, it is important to carefully review internal documentation practices; review any applicable state law or guidance; and establish patient narcotics agreements and consistently monitor and enforce them.

The recovery audit contractor ("RAC") for Region B covering the Midwestern states, CGI Federal, Inc., is requesting additional documentation from providers regarding facet joint injections without reported imaging guidance (CPT codes 64470-64476). The requests for additional documentation acknowledge that CMS has not yet approved this issue for complex review and further acknowledge that the RAC Statement of Work mandates that no improper payments may be recovered until CMS approves the area for complex review. However, the RAC is requesting documentation to determine whether overpayments exist. If overpayments are identified, the claims will not be sent to the Medicare claims processor for adjustment unless and until CMS approves the topic of facet joint injections for complex review.

According to the RAC, the issue of facet joint injections was identified for review based upon the OIG report related to facet joint injections, the National Government Services, Inc. ("NGS") local coverage determination ("LCD") covering pain management, Coding and Compliance Focus News and an American Society of Anesthesiologists ("ASA") Committee on Economics Memorandum.

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